CRED ERP 25

01/07/2025

⚫ Considerations for SMEs

Reg. (EC) No 2049/2005

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Assignment of SME status

• Registration with EMA SME Office

• For enterprises/applicants within EU/EEA

• SME criteria defined in Recommendation 2003/361/EC:

⚫ Headcount <250 and annual turnover not more than € 50 mil or balance sheet not more than € 43 mil.

• Partner enterprises and linked enterprises affect the calculation

• Submit information to show compliance with criteria

• Limited validity, renewable

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